The US Food and Drug Administration (FDA) has issued its Final Rule in officially making explicit that In Vitro diagnostic products (IVD), also known as laboratory-developed tests (LDT), are medical devices under the Federal Food, Drug, and Cosmetic Act.
The FDA announced the final rule on 29 April, aimed at giving the body greater oversight into how LDTs are designed and validated for use amid concern that such tests are becoming increasingly frequent across a number of indications and facilities.
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The FDA has now issued a policy confirming that over the course of the next four years, it will phase out its current discretionary approach towards LDTs, issuing targeted enforcement discretion policies for certain categories of IVDs manufactured by laboratories.
The government body has said that the decision comes in response to numerous examples brought to its attention of potentially inaccurate, unsafe, ineffective, or poor-quality IVDs offered as LDTs that may have resulted in patient harm. These include tests used to select cancer treatment, aid in the diagnosis of Covid-19, aid in the management of patients with rare diseases and identify a patient’s cancer risk.
Robert Califf, FDA Commissioner, said: “LDTs are being used more widely than ever before – for use in newborn screening, to help predict a person’s risk of cancer or aid in diagnosing heart disease and Alzheimer’s. The agency cannot stand by while Americans continue to rely on the results of these tests without assurance that they work.
“The final rule announced today aims to provide crucial oversight of these tests to help ensure that important health care decisions are made based on test results that patients and health care providers can trust.”
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By GlobalDataThe ruling comes following years of negotiation back and forth with industry bodies and individual companies with the FDA enacting a four-year phase-out of its discretionary approach as a result of learning just how widespread the use of LDTs is. The FDA says that it intends to exercise enforcement discretion over premarket review and most quality system requirements for the tests.
However, the move has still been met with industry pushback, notably against elements in the final rule that allow the FDA to exercise its discretion over LDTs still currently on the market. Utah-based research group, ARUP Laboratories, criticised the final wording of the ruling, stating that it believes the FDA does not have statutory authority over LDTs and that the rule will limit access to essential testing services and stifle innovation.
Chief medical officer and senior director of governmental affairs at ARUP Laboratories, Jonathan Genzen, said: “We are disappointed that the FDA enacted the rule, denying many stakeholders the opportunity to collaborate on an oversight framework aligned with clinical laboratory expertise and resources in order to better protect patients and future innovation.
“ARUP is evaluating and reviewing the final rule, including any changes, internally and with our industry partners, to determine the next steps.”
